the Crono Five and Crono PCA 50 has been designed for use in subcutaneous, intravenous, epidural and intrathecal infusions of prescribed liquid medicines.

Device Description

Crono Five is a new, innovative ambulatory infusion pump that is very appreciated by health care professionals and patients due to its small size and technical features. Crono Five is especially suited for controlled drug administration on patients in hospital or undergoing a therapy at home. The pump is suitable for subcutaneous, intra-venous, epidural and intrathecal infusions allowing 4 different administration modalities: 1. Continuous 2. Bolus dose upon request (PCA) 3. Clinician bolus (managed by clinician) 4. Combined (continuous + bolus upon request + clinician bolus). Crono Five pump uses dedicated syringes which are available in two sizes: 10 and 20 ml. The pump is provided with key-pad lock-out functions in order to avoid un-authorized reprogramming of the drug administration protocol. The liquid crystal display (LCD) can show relevant information to caregivers and patients like programmed values, amount of drug delivered, remaining delivery time etc. Crono PCA 50 is essentially the same as the Crono Five, but has a 50 ml infusion capacity.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Crono Five and Crono PCA 50 ambulatory infusion pumps. However, it does not contain the level of detail typically found in a study that proves a device meets specific acceptance criteria, especially for AI/ML-driven devices.

Based on the information provided, here's an attempt to answer the questions, highlighting what is available and what is not:

1. A table of acceptance criteria and the reported device performance

The document presents a comparison table between the new devices (Crono Five and Crono PCA 50) and a predicate device (Crono PCA - K013822; though Crono go - K013840 is listed under physical characteristics). While this table shows performance characteristics, it doesn't explicitly state "acceptance criteria" against which these performances are measured in a quantifiable sense, beyond general equivalence.

Characteristic	Crono PCA - K013822 (Predicate Device)	Crono Five / Crono PCA 50 (New Device)	Acceptance Criteria (Implied)	Reported Performance (New Device)
Intended Use	subcutaneous, intra-venous, epidural and intrathecal infusions of prescribed liquid medicines.	SAME	Be equivalent to predicate	Same as predicate
Physical characteristics	Crono go - K013840 (for size/weight)	Crono Five / Crono PCA 50	Be equivalent to predicate	Crono Five: 77x48x29 mm, 115g. Crono PCA 50: 84.5x55x42 mm, 140g. (Size and Weight vary from "SAME" for Crono Five and Crono PCA 50, but are considered acceptable in the context of similarity to Crono go)
Size	3" x 1.85" x 1.14" (77 x 48 x 29 mm)	SAME (for Crono Five); 84.5 x 55 x 42 mm (for Crono PCA 50)	Be comparable to predicate	Crono Five: 77x48x29 mm. Crono PCA 50: 84.5x55x42 mm.
Weight	4.0 oz (115 g) (battery included)	SAME (for Crono Five); 140 g (battery included) (for Crono PCA 50)	Be comparable to predicate	Crono Five: 115g. Crono PCA 50: 140g.
Battery	Power Source Lithium battery (3V) of the 123 A type.	SAME	Be equivalent to predicate	Same as predicate
Infusion per impulse	22 μl.	Crono Five: 5 μl. Crono PCA 50: 20 μl.	Achieve intended infusion rates and volume with sufficient precision	Crono Five: 5 μl. Crono PCA 50: 20 μl. (These are different but considered acceptable for purpose.)
Flow rate accuracy	+/-2%.	Crono Five: +/-2%. Crono PCA 50: +/-3%.	Maintain acceptable flow rate accuracy for intended use	Crono Five: +/-2%. Crono PCA 50: +/-3%.
Max. Occlusion pressure	4.5 bar +/-1 bar.	Crono Five: 2.2 bar +/-0.5 bar. Crono PCA 50: 2.2 bar +/- 0.5 bar.	Have an appropriate safety margin for occlusion pressure	Crono Five: 2.2 bar +/-0.5 bar. Crono PCA 50: 2.2 bar +/- 0.5 bar. (Different but presumably within safe operating limits).
Capacity	10 or 20 ml.	10, 20 ml or 50 ml.	Meet desired capacity range	10, 20 ml or 50 ml.

The primary "acceptance criterion" articulated is "Substantial Equivalence" to the legally marketed predicate device (Crono, K041414). The study (as described) aims to demonstrate that the new device is "as safe and effective" as the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "bench, EMC, and user testing." It does not specify the sample size for these tests (e.g., number of devices tested, number of users involved). The provenance of the data is not explicitly stated beyond the fact that the company (Canė S.r.l.) is based in Italy. It's not clear if the user testing was prospective or retrospective; bench and EMC testing are generally prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The context of this device (infusion pump) suggests that "ground truth" would be established through engineering specifications, calibration standards, and clinical performance assessments rather than expert interpretation of medical images or data. There's no indication of experts in the sense of medical diagnosticians establishing ground truth. "User testing" would involve healthcare professionals, but their number and specific qualifications for establishing ground truth are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Given the nature of this device (an infusion pump) and the type of testing mentioned (bench, EMC, user testing), an "adjudication method" in the context of expert consensus for diagnostic interpretation is not applicable. Testing would likely involve adherence to engineering standards and verification procedures.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for AI/ML diagnostic or image analysis tools where human readers’ performance is being evaluated with and without AI assistance. The Crono Five and Crono PCA 50 are infusion pumps, not AI/ML diagnostic tools.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device is an infusion pump, which is a hardware device with embedded software for controlling the infusion process. It's not an AI/ML algorithm in the context of standalone diagnostic performance. The "bench testing" would represent the standalone performance of the device against its specifications, but not in the sense of an algorithm operating without human intervention for diagnostic purposes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For an infusion pump, the "ground truth" for performance characteristics (like flow rate accuracy, infusion per impulse, occlusion pressure) would be established by:

Engineering specifications and standards: Adherence to defined physical and performance parameters, often verified with calibrated equipment.
Bench testing: Measuring actual output against expected output using precise instrumentation.
User feedback/testing: Verifying that the device operates as intended in a clinical or simulated clinical environment and meets user requirements for usability and safety.

There is no mention of expert consensus, pathology, or outcomes data in the sense of a medical diagnostic study.

8. The sample size for the training set

This information is not applicable as the device is not described as an AI/ML system that undergoes a "training set" process. It's a medical device (infusion pump) whose performance is established through traditional engineering and clinical testing.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

Summary

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NOV 2 3 2005

MEDICAL TECHNOLOGY

Canė S.r.l. società unipersonale
P.IVA - Reg. Impr. TO: 04384410017
R.Ε.Α. ΤΟ Ν. 629783
Cap. Soc. Euro 10.400 i.v.

Image /page/0/Picture/4 description: The image shows a logo for CERMET, which is a certification organization. The logo includes the text "CERMET" in bold letters, along with the phrase "SISTEMA DI GESTIONE CERTIFICATO". Below this, it indicates compliance with standards REG. N. 3506, UNI EN ISO 9001:2000, and ISO 13485:2003.

EXHIBIT 2

CANÈ S.r.l. Via Pavia, 105/I 10090 Rivoli-Cascine Vica (Torino) Italy Tel.: ++39-011-957.48.72 Fax ++39-011-959.88.80 Contact: Mario Cané. President July 4, 2005

510(k) Summary

Identification of the Device: Proprietary - Trade Name: Crono Five and Crono PCA 50. Classification Name: 80 FRN. Common/Usual Name: Ambulatory Infusion Pump.

2. Equivalent legally marketed devices

This product is similar in function and design to the Crono cleared under 510(k) number K041414.

3. Indications for Use (intended use)

The portable Crono Five and Crono PCA 50 infusion devices have been designed for use in subcutaneous infusion of prescribed liquid medicines.

4. Description of the Device

Crono Five is a new, innovative ambulatory infusion pump that is very appreciated by health care professionals and patients due to its small size and technical features.

Crono Five is especially suited for controlled drug administration on patients in hospital or undergoing a therapy at home. The pump is suitable for subcutaneous, intra-venous, epidural and intrathecal infusions allowing 4 different administration modalities:

1. Continuous

1. Bolus dose upon request (PCA)
1. Clinician bolus (managed by clinician)
1. Combined (continuous + bolus upon request + clinician bolus)

Crono Five pump uses dedicated syringes which are available in two sizes: 10 and 20 ml.

SINGERI

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SINGERT

Image /page/1/Picture/2 description: The image shows a logo or wordmark that includes a stylized cross-like symbol on the left, followed by the word "CANE" in bold, sans-serif font. The cross symbol is formed by thick, black bars arranged to create a symmetrical shape with a white space in the center. The letters in "CANE" are also constructed from thick, black bars, giving them a blocky and modern appearance. The overall design is simple, bold, and visually striking.

MEDICAL TECHNOLOGY
Canė S.r.l. società unipersonale
P.IVA - Reg. Impr. TO: 04384410017
R.Ε.Α. ΤΟ Ν. 629783
Cap. Soc. Euro 10.400 i.v.

Image /page/1/Picture/4 description: The image shows a logo for CERMET, which is a certification organization. The logo includes the text "CERMET" in a bold font, along with the phrase "SISTEMA DI GESTIONE CERTIFICATO". Below this, it states "REG. N. 3506" and "UNI EN ISO 9001:2000". The logo is contained within a rounded rectangular shape.

The pump is provided with key-pad lock-out functions in order to avoid un-authorized reprogramming of the drug administration protocol.

The liquid crystal display (LCD) can show relevant information to caregivers and patients like programmed values, amount of drug delivered, remaining delivery time etc.

Crono PCA 50 is essentially the same as the Crono Five, but has a 50 ml infusion capacity.

5. Safety and Effectiveness, comparison to predicate device.

The results of bench, EMC, and user testing indicates that the new device is as safe and effective as the predicate device.

Characteristic	Crono PCA - K013822	Crono FiveCrono PCA 50
Intended Use	subcutaneous, intra-venous,epidural and intrathecalinfusions of prescribedliquid medicines.	SAME
Physical characteristics	Crono go - K013840	Crono FiveCrono PCA 50
Size	3" x 1.85" x 1.14" (77 x 48x 29 mm).	SAMEFor Crono PCA 50: 84.5 x55 x 42 mm.
Weight	4.0 oz (115 g) (batteryincluded).	SAMEFor Crono PCA 50: 140 g(battery included).
Battery	Power Source Lithiumbattery (3V) of the 123 Atype.	SAME
Infusion per impulse	22 μl.	Crono Five: 5 μl.Crono PCA 50: 20 μl.
Flow rate accuracy	+/-2%.	Crono Five: +/-2%.Crono PCA 50: +/-3%.
Max. Occlusion pressure	4.5 bar +/-1 bar.	Crono Five: 2.2 bar +/-0.5bar.Crono PCA 50: 2.2 bar +/-0.5 bar.
Capacity	10 or 20 ml.	10, 20 ml or 50 ml.

6. Substantial Equivalence Chart

7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of CANÈ S.r.I. that Crono pumps are as safe and effective as the predicate device, has few software differences, and has no new indications for use, thus rendering it substantially equivalent the predicated device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 2005

Cane S.R. L. Mr. Carlo Musso Quality Manager Via Pavia, 105/I Rivoli-Cascine Vica (Torino), ITALY 10090

Re: K052218

Trade/Device Name: CRONO FIVE AND CRONO PCA 50 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: II Product Code: FRN and MEA Dated: September 21, 2005 Received: September 26, 2005

Dear Mr. Musso:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Musso

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sulta y. Mckin Omd

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the word "CANE" in bold, black letters. To the left of the word is a symbol that looks like two mirrored "C" shapes, also in bold black. The letters are sans-serif and appear to be part of a logo or title. The background is plain and white, which makes the black text stand out.

VED CAL TECHNOLOGY

Canė S.r.l. società unipersonale
P.IVA - Reg. Impr. TO: 04384410017
R.Ε.Α. ΤΟ Ν. 629783
Cap. Soc. Euro 10.400 i.v.

Image /page/4/Picture/2 description: The image shows a logo with the word "CERMET" in bold letters. Below the word CERMET are the words "SISTEMA DI GESTIONE CERTIFICATO" stacked on top of each other. At the bottom of the logo are the words "REG. N. 3506" followed by "UNI EN ISO 9001:2000" and "ISO 13485:2002".

SINGERT

j) Indications for Use

Koszug 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Crono Five and Crono PCA 50.

Indications For Use: the Crono Five and Crono PCA 50 has been designed for use in subcutaneous, intravenous, epidural and intrathecal infusions of prescribed liquid medicines.

Prescription Use X . (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joon Lir. For ADW al

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Control, Dental Devices

Koszus 510(k) Number:_

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).